Fierce Pharma

SEPTEMBER 18, 2024

With its latest acquisition, women’s health outfit Organon is bringing its dermatology business to the U.S. with a potential blockbuster in tow. | Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant for up to $1.2 billion, the companies announced Wednesday. The crown jewel of the deal is undoubtedly Vtama, Dermavant’s steroid-free cream for plaque psoriasis, which is looking at a major expansion opportunity in eczema.

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MedCity News

SEPTEMBER 18, 2024

While fibrates are proven to lower triglyceride levels, which can serve as a biomarker for cardiovascular disease risk, several major clinical studies from the past 20 years have failed to show a benefit of fenofibrates over and above statins in further reducing heart-related events. The post Millions are Taking a Drug that Falls Short of its Promise to Lower Risk of Heart Attack appeared first on MedCity News.

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Fierce Pharma

SEPTEMBER 18, 2024

This summer, GSK cut its yearly vaccine sales projection o | In the study, co-administration of GSK's RSV vaccine Arexvy and shingles shot Shingrix elicited non-inferior immune responses compared with separate administration of the vaccines.

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MedCity News

SEPTEMBER 18, 2024

By acquiring Dermavant, Organon gets Vtama, a drug approved for treating plaque psoriasis. An FDA decision for the topical cream in atopic dermatitis is expected by the end of 2024. The post Organon Gets More Skin in the Game by Acquiring Roivant’s Dermatology Subsidiary appeared first on MedCity News.

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Fierce Pharma

SEPTEMBER 18, 2024

Since GSK’s Nucala and AstraZeneca’s Fasenra were approved two years apart to treat patients with severe asthma, the IL-5 inhibitors have engaged in a spirited market battle, with one key differenc | Locked in a spirited market battle with GSK's Nucala, AstraZeneca's Fasenra is catching up with its IL-5 inhibitor rival as the FDA signed off on its use to treat the rare autoimmune condition of eosinophilic granulomatosis with polyangiitis.

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pharmaphorum

SEPTEMBER 18, 2024

PBM Express Scripts has sued the FTC, claiming its recent report on the sector's role in drug pricing is defamatory and should be retracted

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MedCity News

SEPTEMBER 18, 2024

During a panel at the MedCity News INVEST Digital Health conference, three healthcare execs shared advice to startups on how to pitch to employers. They need to know their worth, understand the problem they’re solving, and think about issues globally. The post How Should Healthcare Startups Approach Employers? 3 Execs Weigh In appeared first on MedCity News.

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pharmaphorum

SEPTEMBER 18, 2024

Digital health company Noom has launched a compound pharmacy-made version of Novo Nordisk's obesity drug semaglutide to make the drug more accessible to consumers in the US.The bold move has been accompanied by a full-page ad in the Wall Street Journal explaining its reasoning, and claiming that the prices of GLP-1 drugs for weight loss are five times too high and need to be brought in line with levels in other countries.

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MedCity News

SEPTEMBER 18, 2024

The current model of siloed, proprietary development is failing us. It’s slow, expensive, and often results in technologies that never see the light of day. What if, instead, we embraced an open-source approach to medical device innovation? The post The FDA Isn’t Blocking Medical Breakthroughs — Our Outdated Innovation Model Is appeared first on MedCity News.

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PharmaVoice

SEPTEMBER 18, 2024

Overpromising, overcommitting and neglecting CMC are a few of the pitfalls that cause sponsors to stumble when submitting a new drug application.

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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MedCity News

SEPTEMBER 18, 2024

In recent years, providers have been increasingly conducting tech pilots to see which solutions can best improve their clinical and operation success. During a panel at MedCity News’ INVEST Digital Health conference in Dallas, healthcare leaders shared their insight on how startups can best serve their provider partners during these pilots. The post 4 Things Startups Must Know to Achieve a Successful Tech Pilot appeared first on MedCity News.

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Evolve Your Success

SEPTEMBER 18, 2024

Unlock the secrets to excelling in medical sales! This episode promises to inspire and educate as we welcome Jon Alwinson, a veteran in the endoscopy sector, to share his remarkable career journey. Delve into Jon’s personal story, from the influence of his author father to his own four-year endeavor of writing a book aimed at guiding future medical sales reps.

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PharmaTech

SEPTEMBER 18, 2024

The drug manufacturing ecosystem Pharma 4.0, a term coined in 2017 by the International Society for Pharmaceutical Engineers, promises a revolution across drug discovery, manufacturing, and supply chain logistics, ensuring drugs are delivered precisely when needed, and improving overall patient care.

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PM360

SEPTEMBER 18, 2024

Conshohocken, Pa., September 18, 2024 – Deerfield Group, one of the fastest-growing independent marketing and communications partners for healthcare and life science brands and companies, today announced two additions to its executive leadership team: Guy Varady will serve as Executive Vice President, Integrated Marketing, and Bob Josefsberg as Executive Vice President, Communications.

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PharmExec

SEPTEMBER 18, 2024

Approval was based on data from the IND.227/KEYNOTE-483 trial, which demonstrated a 21% reduction in the risk of death when Keytruda was added to chemotherapy in patients with unresectable advanced or metastatic malignant pleural mesothelioma.

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Progressive Medical

SEPTEMBER 18, 2024

There is no excerpt because this is a protected post. The post Protected: Melling Medical and Progressive Medical, Inc. Form Strategic Partnership to Enhance Federal Health Care appeared first on Progressive Medical, Inc.

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PharmExec

SEPTEMBER 18, 2024

Approval was based on results from the MANDARA Phase III trial, which demonstrated the superiority of Fansenra over Nucala in patients with eosinophilic granulomatosis with polyangiitis.

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Pharmaceutical Commerce

SEPTEMBER 18, 2024

Accord BioPharma's 420 mg strength Hercessi (trastuzumab-strf), a biosimilar to Herceptin, gains FDA approval to treat HER2-overexpressing breast cancer and gastric cancer.

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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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PharmExec

SEPTEMBER 18, 2024

Ten-year data from the Phase III KEYNOTE-006 trial found that Keytruda produced a 34% ten-year overall survival rate compared to 23.6% for ipilimumab in patients with advanced melanoma.

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pharmaphorum

SEPTEMBER 18, 2024

Novartis' Kisqali has claimed a broad FDA approval in early breast cancer that could give it an edge over rival Verzenio from Eli Lilly

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PharmExec

SEPTEMBER 18, 2024

Results from the Phase II PHAROS trial found that treatment-naïve patients with BRAF V600E-mutant metastatic non-small cell lung cancer administered Braftovi in combination with Mektovi achieved an objective response rate of 75%.

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Pharmaceutical Technology

SEPTEMBER 18, 2024

At the Clinical Trial Supply West Coast 2024 conference, serial biotech entrepreneur Umar Hayat said science should be allowed to advance without political interference.

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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PharmaVoice

SEPTEMBER 18, 2024

The FDA’s backlog of overseas drug manufacturer inspections is still mounting — and new drugs could be delayed as a result.

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PharmaTimes

SEPTEMBER 18, 2024

The conference will return to Vienna AirportCity on 23 to 24 October 2024

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Pharmaceutical Technology

SEPTEMBER 18, 2024

Japan's MHLW has accepted for review GSK's NDA for Blenrep for patients with relapsed or refractory multiple myeloma.

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PharmExec

SEPTEMBER 18, 2024

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Pharmaceutical Technology

SEPTEMBER 18, 2024

Ossium Health’s PRESERVE I trial is evaluating the safety and effectiveness of its deep-frozen bone marrow from deceased organ donors.

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PharmExec

SEPTEMBER 18, 2024

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Pharmaceutical Technology

SEPTEMBER 18, 2024

Kisqali generated $2bn in sales last year, with broader approvals forecasting sales of over $8bn by 2030, per GlobalData analysis.

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PharmExec

SEPTEMBER 18, 2024

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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